A global Medical Device Company in Irvine, CA is looking to identify and hire an Engineer I who will will be working on various projects and devices to develop the required testing needs. This is a high visibility position and has potential career growth opportunities working side by side with leading experts in this field.This is an exciting opportunity to join an advanced technology business unit to work with a dedicated team focused on the development and expansion of our new engineer testing capabilities.
- Execute in-vitro and in-vivo protocols/reports for the testing of a class III cardiovascular implants per associated ISO and FDA standards.
- Development of in-vitro test systems and simulations that apply to human physiologic and anatomic conditions to evaluate various designs and performance characteristics.
- Support the development of new test methods, procurement of tooling and equipment and executing long term testing for implants & delivery systems under the direction of a project leader.
- Prepare test protocols and technical reports which summarize data and provide the team with insightful analysis of results from experimentation.
- Testing includes, but is not limited to, in-vivo animal studies, simulated physiological hydrodynamic pulsatile testing, steady state hydraulic testing, and cadaver studies.
- Must be able to work with Cadaver tissue, prior human tissue handling is preferred.
- Work closely with project team members, internal partners in the Regulatory, Quality, Manufacturing and other departments to deliver project objectives.
- Bachelor's degree in Engineering; Mechanical or Biomedical.
- Familiar with 3D modeling: CREO, SolidWorks and/or AutoCAD.
- Experience working with human tissue and handling cadaver hearts is a plus.
- Strong mechanical aptitude, including hands-on skills with proven ability to apply technical knowledge and judgment to complex technical problems is required.
- Highly effective verbal and written communication skills are necessary.
- Ability to solve technical problems as well as identify and implement practical solutions based on device requirements and project timelines.
- Demonstrated project ownership and accountability for project results.
- Must be a highly motivated self-starter able to achieve results with minimal direction.
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
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